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Also known as denufosol tetrasodium (INS37217), denufosol tetrasodium (INS37217) Inhalation Solution, denufosol tetrasodium Inhalation Solution
denufosol tetrasodium · 7 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 2 | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | Denufosol Tetrasodium (INS37217) Inhalation Solution |
| denufosol tetrasodium Inhalation Solution | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Denufosol Tetrasodium (INS37217) Inhalation Solution | DRUG | Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months. |
| Placebo | DRUG | Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months. |
| Placebo - 0.9% w/v sodium chloride solution | DRUG | 4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months. |
| denufosol tetrasodium Inhalation Solution | DRUG | 60 mg by oral inhalation three times daily |
| 0.9% w/v sodium chloride solution | DRUG | 0.9% w/v sodium chloride solution by oral inhalation three times daily |
| denufosol tetrasodium (INS37217) | DRUG | - |
Inclusion Criteria: * Have confirmed diagnosis of cystic fibrosis * Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height * Be able to reproducibly perform spirometry * Be clinically stable for at least 4 weeks before screening Exclusio...
Top 6 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vertex Pharmaceuticals Incorporated | VRTX | 8 | PHASE3 | Alyftrek, Trikafta, Ivacaftor, VX-581, VX-272 |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| 4D Molecular Therapeutics, Inc. | FDMT | 1 | PHASE2 | 4D-710 |
| Arcturus Therapeutics Holdings, Inc. | ARCT | 1 | PHASE2 | ARCT-032 |
| Krystal Biotech, Inc. | KRYS | 1 | PHASE1 | KB407 |
| Roivant Sciences Ltd. | ROIV | 1 | PHASE1 | SP-101 |
Denufosol tetrasodium is an investigational inhaled therapy that was studied for the treatment of cystic fibrosis lung disease. It was evaluated in patients with mild cystic fibrosis as well as in pediatric patients aged 2 years and older. It is not an approved treatment.
Denufosol tetrasodium is a small molecule agonist of P2RY2, a purinergic receptor. By activating this receptor, the drug was designed to stimulate chloride and fluid secretion in the airways, which was intended to improve mucus clearance in patients with cystic fibrosis lung disease.
Denufosol tetrasodium was developed by Merck & Company, Inc., which trades under the ticker MRK. The company sponsored the clinical development program for the drug in cystic fibrosis.
Denufosol tetrasodium reached Phase 3 clinical development for cystic fibrosis. Seven clinical trials have been completed, including two Phase 3 studies, and no trials are currently active. The drug is investigational and has not been approved for any indication.
Denufosol tetrasodium has been studied in seven completed trials, including NCT00625612, a Phase 3 study in cystic fibrosis lung disease with 466 patients, and NCT00357279, a Phase 3 study in mild cystic fibrosis lung disease with 352 patients. Pediatric studies include NCT01181622 and NCT00130182.
Yes. Denufosol tetrasodium is also known as INS37217. The names denufosol tetrasodium (INS37217), denufosol tetrasodium (INS37217) Inhalation Solution, denufosol tetrasodium Inhalation Solution, and Denufosol Tetrasodium (INS37217) Inhalation Solution all refer to the same investigational compound.